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E-grāmata: Pharmacovigilance Medical Writing: A Good Practice Guide

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(Director, Acadustri (Medical Writing) Ltd and Visiting Lecturer, University of Hertfordshire, UK)
  • Formāts: EPUB+DRM
  • Izdošanas datums: 22-Jun-2012
  • Izdevniecība: Wiley-Blackwell
  • Valoda: eng
  • ISBN-13: 9781118302064
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Pharmacovigilance Medical Writing: A Good Practice GuidePalielināt
  • Formāts: EPUB+DRM
  • Izdošanas datums: 22-Jun-2012
  • Izdevniecība: Wiley-Blackwell
  • Valoda: eng
  • ISBN-13: 9781118302064
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Pharmacovigilance Medical Writing covers the preparation of pharmacovigilance documents for all stages of the drug development process (i.e. from clinical development through to applications for marketing authorisations to the post-marketing stage). For each document, the book presents a review of the regulatory framework that governs the content of the document, followed by practical guidance (e.g. scheduling, source data, department/functions involved in document preparation/review, appropriate timelines and planning activities), ending with a generic model document compliant with the current guidelines, which can be modified to meet specific company and product requirements.

Recenzijas

This book is well structured and should prove useful for pharmacovigilance scientists and writers to have a reference text and checklist for regulatory pharmacovigilance documentation requirements.  (Pharmaceutical Journal, 9 February 2013)

Preface - Pharmacovigilance Medical Writing Comes of Age ix
Acknowledgements xiii
Abbreviations xv
1 Pharmacovigilance Medical Writing - An Overview Across the Drug Development Process 1(4)
2 Pharmacovigilance Medical Writing for Clinical Trials 5(28)
2.1 Introduction
5(1)
2.2 The EU Annual Safety Report and US IND Annual Report - A Historical Look at Reporting from Clinical Studies
6(3)
2.3 The Development Safety Update Report
9(21)
2.4 References
30(3)
3 Pharmacovigilance Medical Writing for Marketing Authorization 33(42)
3.1 Introduction
33(1)
3.2 The Summary of Clinical Safety
34(26)
3.3 The Integrated Summary of Safety
60(13)
3.4 The 120-Day Safety Update Report
73(1)
3.5 References
74(1)
4 Pharmacovigilance Medical Writing in Risk Evaluation and Management 75(42)
4.1 Introduction
75(1)
4.2 The EU Risk Management Plan
76(20)
4.3 The Risk Evaluation and Mitigation Strategies Report
96(10)
4.4 The Benefit-Risk Evaluation Report
106(8)
4.5 References
114(3)
5 Pharmacovigilance Medical Writing for Marketed Products 117(54)
5.1 Introduction
117(2)
5.2 The EU Periodic Safety Update Report
119(28)
5.3 The US Periodic Adverse Drug Experience Report
147(10)
5.4 The PSUR Addendum Report
157(6)
5.5 The Summary Bridging Report
163(6)
5.6 References
169(2)
6 The Ad-Hoc Safety Review and Response to Questions Document 171(14)
6.1 Introduction
171(1)
6.2 The Ad-Hoc Safety Review
172(7)
6.3 The Response to Questions Document
179(6)
7 The Rest of the World 185(8)
7.1 Introduction
185(1)
7.2 Japan
186(2)
7.3 Canada
188(1)
7.4 Australia and New Zealand
188(1)
7.5 India
189(1)
7.6 Singapore and Taiwan
190(1)
7.7 References
191(2)
Appendices
Appendix 1: Sample Line Listing
193(4)
Appendix 2: Sample Summary Tabulation
197(2)
Appendix 3: Another Look at the US IND Annual Report
199(12)
Appendix 4: The New Pharmacovigilance Legislation in the EU
211(4)
Appendix 5: The New EU Risk Management Plan
215(12)
Appendix 6: The New EU Periodic Safety Update Report/Periodic Benefit-Risk Evaluation Report
227(26)
Glossary 253(6)
Index 259
Justina Orleans-Lindsay BSc, MSc, PhD is a Director of Acadustri (Medical Writing) Limited and Visiting Lecturer in pharmacovigilance at the University of Hertfordshire, UK.
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